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Drug ReportsDurvalumab
Imfinzi(durvalumab)
Imfinzi (durvalumab) is an antibody pharmaceutical. Durvalumab was first approved as Imfinzi on 2017-05-01. It is used to treat transitional cell carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against programmed cell death 1 ligand 1.
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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Imfinzi
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Durvalumab
Tradename
Proper name
Company
Number
Date
Products
ImfinzidurvalumabAstraZenecaN-761069 RX2017-05-01
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
imfinziBiologic Licensing Application2025-02-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
transitional cell carcinoma—D002295—
Agency Specific
FDA
EMA
Expiration
Code
durvalumab, Imfinzi, AstraZeneca UK Ltd
2029-10-21Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors
— L01FF03: Durvalumab
HCPCS
Code
Description
J9173
Injection, durvalumab, 10 mg
Clinical
Clinical Trials
819 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——205121211100
Lung neoplasmsD008175—C34.901654151485
NeoplasmsD009369—C80221721—38
PneumoniaD011014EFO_0003106J18———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0193711—362
Breast neoplasmsD001943EFO_0003869C5017253——37
Small cell lung carcinomaD055752——7166—433
Squamous cell carcinoma of head and neckD000077195——13152——25
Squamous cell carcinomaD002294——13152——25
Urinary bladder neoplasmsD001749—C676174——25
Hepatocellular carcinomaD006528—C22.05116—424
Triple negative breast neoplasmsD064726——9132——21
Liver neoplasmsD008113EFO_1001513C22.0686—220
Ovarian neoplasmsD010051EFO_0003893C569121——18
Show 14 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230——820———22
Pancreatic neoplasmsD010190EFO_0003860C25915———21
Colorectal neoplasmsD015179——810———16
CholangiocarcinomaD018281—C22.1—10———10
Esophageal neoplasmsD004938—C1546———8
Prostatic neoplasmsD011471—C6126———7
Stomach neoplasmsD013274EFO_0003897C1645———7
MelanomaD008545——52———6
Squamous cell neoplasmsD018307——34———6
Neoplasm metastasisD009362EFO_0009708—43———6
Show 53 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
B-cell lymphomaD016393——2————2
Thyroid neoplasmsD013964EFO_0003841—2————2
Thyroid diseasesD013959—E00-E072————2
Second primary neoplasmsD016609——1————1
Male breast neoplasmsD018567——1————1
Vaginal neoplasmsD014625—C521————1
Vulvar neoplasmsD014846—C511————1
Anaplastic thyroid carcinomaD065646——1————1
Non-hodgkin lymphomaD008228—C85.91————1
Pharyngeal neoplasmsD010610—C14.01————1
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDurvalumab
INNdurvalumab
Description
Durvalumab (human mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>5X8M:B|durvalumab heavy chain EVQLVESGGGLVQPGGSLRLSCAASGFTFSRYWMSWVRQAPGKGLEWVANIKQDGSEKYYVDSVKGRFTISRDNAKNSLY LQMNSLRAEDTAVYYCAREGGWFGELAFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTV SWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTHHHHHH >5X8M:C|durvalumab light chain EIVLTQSPGTLSLSPGERATLSCRASQRVSSSYLAWYQQKPGQAPRLLIYDASSRATGIPDRFSGSGSGTDFTLTISRLE PEDFAVYYCQQYGSLPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB5X8M, 5XJ4
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3301587
ChEBI ID—
PubChem CID—
DrugBankDB11714
UNII ID28X28X9OKV (ChemIDplus, GSRS)
Target
Agency Approved
CD274
CD274
Organism
Homo sapiens
Gene name
CD274
Gene synonyms
B7H1, PDCD1L1, PDCD1LG1, PDL1
NCBI Gene ID
Protein name
programmed cell death 1 ligand 1
Protein synonyms
B7 homolog 1, B7-H1, CD274, CD274 antigen, PDCD1 ligand 1
Uniprot ID
Mouse ortholog
Cd274 (60533)
programmed cell death 1 ligand 1 (Q9EP73)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Imfinzi – AstraZeneca
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 21,394 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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13,776 adverse events reported
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